Visucopt 20 mg/ml + 5 mg/ml eye drops in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Visucopt 20mg/ml + 5mg/ml, eye drops solution in single-dose container (dorzolamide/timolol)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Visucopt single-dose eye drops are and what they are used for
2. What you need to know before using Visucopt single-dose eye drops
3. How to use Visucopt single-dose eye drops
4. Possible adverse effects
5. How to store Visucopt single-dose eye drops
6. Contents of the pack and other information

1. What Visucopt unidosis is and what it is used for

Visucopt unidosis contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines known as "beta-blockers".

These medicines reduce intraocular pressure in different ways.

Visucopt unidosis is prescribed to lower elevated intraocular pressure in the treatment of glaucoma when the use of a beta-blocker alone is not sufficient.

2. What you need to know before using Visucopt unidosis

• if you are allergic to the active substances (dorzolamide hydrochloride, timolol maleate) or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have previously had respiratory problems such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, or prolonged cough)
• if you have a slow heart rate, heart failure, or cardiac rhythm disorders (irregular heartbeat)
• if you have severe kidney problems or severe renal failure, or a history of kidney stones
• if you have excessive blood acidity caused by chloride accumulation (hyperchloremic acidosis)

Warnings and precautions

Talk to your doctor or pharmacist before using Visucopt unidosis if you have or have previously had:

• cardiovascular diseases/coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or suffocation), heart failure, low blood pressure; heart rate abnormalities such as slow heart rate
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol, one of the active substances in Visucopt, may mask the signs and symptoms of hypoglycemia
• overactive thyroid gland, as timolol may mask the signs and symptoms of this condition

Inform your doctor:

• if you are using Visucopt unidosis and need to undergo surgery, as timolol may interfere with the effects of certain medications used during anesthesia
• if you have been diagnosed with myasthenia gravis (muscle weakness)
• if you experience eye irritation or new eye problems such as eye redness or eyelid swelling, contact your doctor immediately
• if you develop an eye infection, suffer an eye injury, undergo eye surgery, or experience other reactions such as the onset of new symptoms or worsening of pre-existing symptoms.

Instilling Visucopt unidosis into the eye may affect the entire body.

Use in children and adolescents

Experience with Visucopt unidosis in infants and children is limited.

Use in elderly patients

In studies with dorzolamide/timolol, the effects of the combination of the two active substances were similar in elderly patients and younger patients.

Use in patients with impaired liver function (hepatic insufficiency)

Inform your doctor of any liver problems you currently have or have had in the past.

Anti-doping tests

Use of this medicine may result in positive doping test results.

Other medicines and Visucopt unidosis

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Visucopt unidosis may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma.

Inform your doctor if you are taking or plan to take medicines to lower blood pressure, to treat heart conditions (cardiopathies), or to treat diabetes.

Inform your doctor:

• if you are taking medicines to lower blood pressure or to treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin).
• if you are taking medicines to treat heart disorders or heart rhythm abnormalities (such as calcium channel blockers, beta-blockers, or digoxin).
• if you are using another eye drop containing an active substance belonging to the class of "beta-blockers"; ask your doctor for further information.
• if you are taking another medication for ocular hypertension (a carbonic anhydrase inhibitor, such as acetazolamide).
• if you are taking medicines known as "monoamine oxidase inhibitors (MAOIs)" used to treat depression.
• if you are taking a medicine belonging to the class of "parasympathomimetics" prescribed to help you urinate. Parasympathomimetics are also a specific type of medicine sometimes used to help normalize bowel movements.
• if you are taking "narcotics" such as morphine, used to treat severe pain.
• if you are taking medicines to treat diabetes.
• if you are taking antidepressants such as fluoxetine and paroxetine.
• if you are taking "sulfonamides".
• if you are taking "quinidine", used to treat heart conditions and certain types of malaria.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy

Visucopt unidosis must not be used during pregnancy.

Use during breastfeeding

Do not use Visucopt unidosis if you are breastfeeding. Timolol may pass into breast milk.

Driving and using machines

The effect of Visucopt unidosis on the ability to drive and operate machinery is minor. However, adverse effects associated with the use of Visucopt unidosis, such as transient blurred vision, may affect your ability to drive or operate machinery. Do not drive or operate machinery until you feel well or until your vision has cleared.

3. How to use Visucopt single-dose

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose and duration of treatment.

The recommended dose is one drop of Visucopt single-dose in the affected eye or eyes, morning and night.

If you are using Visucopt single-dose together with other eye drops, they should be administered at least 10 minutes apart.

Do not change the dose of this medicine without consulting your doctor.

Do not let the container cap touch the eye or surrounding areas. It could become contaminated with bacteria that may cause eye infections leading to serious eye damage, including loss of vision. To avoid possible contamination of the container, wash your hands before using this medicine and keep the container away from contact with any surface. A new single-dose container must be opened immediately before each use; each container contains enough solution for both eyes if your doctor has instructed you to use the drops in both eyes.

Instructions for use

Open the aluminum pouch containing the individual single-dose containers. Record the date of first opening on the pouch.

• Wash your hands and sit or stand in a comfortable position.
• Remove the strip of containers from the pouch.
• Separate one single-dose container from the strip.
• Replace the remaining strip back into the pouch and fold the edge to close it.
• To open the container, twist the tab to break it off.

• Hold the container between your thumb and index finger. Note that the tip of the container should not extend more than 5 mm beyond the edge of the index finger.

• Tilt your head backward or lie down and look upward.
• Gently pull down the lower eyelid to create a pocket between the eyelid and the eye.
• Bring the tip of the single-dose container close to the eye, without touching it.
• Gently press the single-dose container to dispense one drop into the eye, as instructed by your doctor. Do not blink while instilling the drop. Release the lower eyelid.

• Close the eye and press with your finger on the inner corner of the eye for approximately two minutes. This helps prevent the drop from reaching the rest of the body.

• Repeat the process in the other eye if instructed by your doctor.
• Discard the single-dose container and any residual content.

Store the remaining containers in the aluminum pouch and use them within 7 days of opening the pouch. If any containers remain after 7 days from opening the pouch, dispose of them safely and open a new pouch.

If you use more Visucopt single-dose than you should

If you instill too many drops into the eye or accidentally swallow the contents of the container, you may feel dizzy, have difficulty breathing, or notice a slowed heart rate. Contact your doctor immediately.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Visucopt single-dose

It is important that you use Visucopt single-dose as prescribed by your doctor. If you miss a dose, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using Visucopt single-dose

If you wish to stop using this medicine, speak with your doctor first.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Timolol is absorbed into the bloodstream and distributed throughout the body, similar to other ophthalmic medicines.

This may cause adverse effects similar to those observed with oral medications of the same class (beta-blockers). The incidence of adverse effects following ocular administration is lower than with oral administration.

If you experience allergic reactions such as swelling of the face and extremities with difficulty breathing or swallowing, hives, or itchy rash; localized or generalized rash, itching, or a severe and sudden allergic reaction that could be life-threatening, stop using this medicine immediately and contact your doctor without delay.

The following adverse effects have been reported with dorzolamide/timolol eye drops or with one of its components during clinical trials or post-marketing experience:

Very common (may affect more than 1 in 10 patients)

• Burning and stinging of the eyes
• Altered taste

Common (may affect up to 1 in 10 patients)

• Headache
• Redness inside and around the eyes, tearing or itchy eyes, corneal erosion (damage to the layer at the front of the eyeball), swelling or irritation inside and around the eyes, sensation of a foreign body in the eye, reduced corneal sensitivity (failure to notice something in the eye and absence of pain), eye pain, dry eyes, blurred vision
• Sinusitis (feeling of pressure or fullness in the nose)
• Weakness/tiredness and fatigue

Uncommon (may affect up to 1 in 100 patients)

• Depression
• Dizziness, fainting
• Inflammation of the iris (a part of the eye), visual disturbances (including refractive changes in some cases due to discontinuation of miotic treatment)
• Slow heart rate
• Difficulty breathing (dyspnea)
• Indigestion
• Kidney stones

Rare (may affect up to 1 in 1,000 patients)

• Allergic-type reactions such as skin rash, urticaria, itching, in rare cases swelling of lips, eyes and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Sleep problems, nightmares, memory loss
• Cerebral ischemia (reduced blood flow to the brain), worsening of signs and symptoms of myasthenia gravis (a muscle disorder), decreased sexual desire, tingling or numbness of the hands or feet
• Temporary myopia which may resolve upon discontinuation of treatment, detachment of the layer located beneath the retina containing blood vessels after filtration surgery, which may cause visual disturbances due to fluid accumulation, drooping eyelids, double vision, crusting of the eyelids, corneal inflammation (causing visual disturbances), low intraocular pressure
• Ringing in the ears
• Changes in heart rhythm or heart rate, congestive heart failure (a heart condition causing breathing difficulties and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), chest pain, myocardial infarction, low blood pressure, excessive constriction of blood vessels (Raynaud's phenomenon), swelling or coldness of hands and feet, reduced circulation in arms and legs, leg cramps or leg pain when walking (claudication), stroke
• Breathing difficulties, worsening of pulmonary function, runny or congested nose, nosebleeds, constriction of the airways, cough
• Throat irritation, dry mouth, diarrhea
• Skin inflammation due to contact with certain substances (contact dermatitis), hair loss, silvery-white skin rash (psoriasiform rash)
• Systemic lupus erythematosus (an immune disease that may cause inflammation of internal organs)
• Peyronie's disease (which may cause curvature of the penis)

Other adverse effects listed are those commonly observed with the pharmacological class of ophthalmic beta-blockers:

Frequency not known (cannot be estimated from available data)

• Low blood glucose levels
• Heart failure, a type of cardiac rhythm disorder
• Abdominal pain, vomiting
• Muscle pain not caused by exercise
• Sexual dysfunction
• Wheezing
• Sensation of foreign body in the eye (feeling of something in the eye)
• Strong heartbeats, which may be rapid or irregular (palpitations)
• Increased heart rate
• Increased blood pressure
• Abnormal sensitivity of the eyes to light

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Visucopt single-dose units

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect it from light.

After opening the aluminum pouch, store below 25 °C and use within 7 days; any unused containers should be discarded. The single-dose containers should be used immediately after opening; any opened single-dose container with residual medicine must be discarded.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• 20 mg of the active substance dorzolamide 20 mg (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg of the active substance timolol (equivalent to 6.83 mg of timolol maleate).
• The other components are mannitol, sodium citrate, hydroxyethylcellulose, sodium hydroxide, and water for injections.

Appearance of the product and contents of the pack

Visucopt unit dose is a clear, colourless solution.

Each pack contains 6, 12, 18 or 24 aluminium sachets, each containing 5 unit dose polyethylene containers with 0.166 ml of solution. Each carton contains 30, 60, 90 or 120 unit dose containers.

Only some pack sizes may be marketed.

Marketing Authorization Holder VISUfarma S.p.A.

Via Alberto Cadlolo 21-00136 Rome,

Italy

Manufacturer

Genetic S.p.A.,

Contrada Canfora,

84084 Fisciano (SA)

Italy

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/